QA Auditor III
Thermo Fisher Scientific
Summary
The Quality Assurance Auditor III leads complex and/or multi-department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. This role identifies issues impacting quality and regulatory compliance, determines the root cause of non-conformance, and develops strategies to address these issues. The Quality Assurance Auditor III may perform technical document reviews and other GxP activities in support of project work or company processes. Additionally, the Quality Assurance Auditor III provides finished audit reports to management, plans and delivers billable quality services for clients and projects, and may serve as the client contact.
Job description
What You'll Do
- Conduct and/or lead a variety of client, internal or GxP audits and regulatory inspections as requested by senior management
- Lead directed site audits, facility, vendor and/or sub-contractor audits
- Provide GxP consultation and support to project teams and external clients
- Lead process audits and may participate as a co-auditor in more complex system audits
- Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
- Contacted by others to serve as a resource to operational departments on audit or quality assurance subject matter
- Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings
- Provide mentorship and guidance to junior auditors
Education & Experience Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years'). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities
- Detailed knowledge of GxP and appropriate regional research regulations and guidelines
- Demonstrated proficiency and led a range of project based or internal GxP audits and vendor audits to high standards required by management
- Excellent oral and written communication skills
- Strong problem solving, risk assessment and impact analysis abilities
- Solid experience in root cause analysis
- Above average negotiation and conflict management skills
- Flexible and able to multi-task and prioritize competing demands/work load
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
Working Conditions and Environment
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves.
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous QA experience comparable to 5+ years
- Detailed knowledge of GxP and appropriate regional research regulations and guidelines
- Demonstrated proficiency leading project based or internal GxP audits and vendor audits
- Excellent oral and written communication skills
- Strong problem solving, risk assessment and impact analysis abilities
- Solid experience in root cause analysis
- Above average negotiation and conflict management skills
- Flexible and able to multi-task and prioritize competing demands/work load
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
Benefits
- Medical, Dental & Vision
- Health Incentive Programs
- Employee Assistance Program
- Family Support Programs
- Commuter Benefits
- Tuition Reimbursement
- 120 Hours PTO
- 10 Paid Holidays
- Paid Parental Leave
- Accident & Life Insurance
- Short & Long-Term Disability
- 401(k) Matching
- Employee Stock Purchase Plan
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.